Clinical Research Associate II (Neurology, Oncology, Rare Disease, Pediatrics)

Premier Research Group; Deutschland; Remote; EUR 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Remote work

Zusammenfassung

Premier Research Group is seeking a Clinical Research Associate II to support Neurology, Oncology, Rare Disease, and Pediatrics programs from a remote Germany location. You will plan and conduct monitoring visits (onsite or remote), ensure data integrity, and maintain trial master files in compliance with ICH/GCP.

The role demands 4+ years of clinical research experience and a licensed health-care background or equivalent.

Qualifikationen

• Undergraduate degree or international equivalent in clinical, science, or health-related field; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
• Previous clinical research experience required.
• At least 4+ years’ experience in clinical trials and independent monitoring.
• Experience across Neurology, Oncology, Rare Disease and Pediatrics preferred.
• Preference for experience across phases I–IV, with Phase II/III considered.

Aufgaben

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines.
• Maintains submission of expenses according to travel and expense requirements within company guidelines.
• Monitors (remote, onsite, or other approved mode) with a focus on data integrity and patient safety per regulations.
• Plans day-to-day monitoring activities and sets priorities per site.
• Prepares for and conducts on-site qualification, study initiation, interim monitoring, and close-out visits as required.
• Maintains TMF/eTMF per filing guidelines and ICH/GCP Section 8.

Kenntnisse

Clinical research

Monitoring visits

TMF management

ICH/GCP

Data integrity

Patient safety

Remote monitoring

Ausbildung

Bachelor in clinical/health

Tools

eTMF

Jobbeschreibung

## Clinical Research Associate II (Neurology, Oncology, Rare Disease, Pediatrics)Apply: Remote: Germany: Full time: Posted 18 Days Ago: R6695Premier Research is looking for a Clinical Research Associate II (Neurology, Oncology, Rare Disease, Pediatrics) to join our Clinical Monitoring, Site Management and SSU team.You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.* We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.* Your ideas influence the way we work, and your voice matters here.* As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.Join us and build your future here.**What You'll be Doing:*** Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines* Maintains submission of expenses according to travel and expense requirements within company guidelines* Monitors (remote, onsite, or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations* Plans day to day activities for monitoring of a clinical study and sets priorities per site* Prepares for and conducts on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites as required by clinical monitoring plan* Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Understands the required essential documents according to ICH/GCP Section 8.* Reviews site documents and verifies they are accurate, complete, current, and include required updates**What we are searching for:*** Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required* Previous clinical research experience required* At least 4+ years’ experience in clinical trials and independent monitoring* **Experience working ideally across all, if not some, of the following therapy areas; Neurology, Oncology, Rare Disease and Pediatrics*** **Preference at working across all phases I-IV, although phase II and III only will be considered****There will be an expectation for country-wide monitoring with the average frequency of days on site being 6 days per month.****You must be located in Germany to be considered for this position.**